Chronic Atrophic Candidiasis, Denture Stomatitis
Conditions
Keywords
Chitosan, Nanoparticles, Nystatin, Oral Candidiasis
Brief summary
The purpose of this study is to evaluate and compare the clinical efficacy of a 1% nanochitosan solution versus a standard Nystatin oral suspension in patients diagnosed with Newton's type II denture stomatitis (chronic atrophic candidiasis). Chitosan nanoparticles are investigated as a potential biocompatible, mucoadhesive alternative to traditional antifungal treatments to accelerate mucosal healing and reduce the erythema of the palatal mucosa.
Detailed description
Denture stomatitis is a common oral mucosal lesion, primarily caused by Candida species under dental prostheses. This randomized single-blind clinical trial investigates the therapeutic properties of a novel 1% nanochitosan formulation synthesized via ionic gelation technique. Eligible participants with Newton's type II denture stomatitis are randomly allocated into two parallel groups. The intervention group receives the 1% nanochitosan solution, and the active control group receives a standard Nystatin oral suspension (100,000 U/mL). Both groups apply 2 mL of their respective medications topically as an oral rinse four times a day for a total duration of 2 weeks. Prior to each application, patients are instructed to remove their dentures to maximize mucosal contact. Clinical outcomes, specifically the change in the erythematous lesion area of the palatal mucosa (measured in square millimeters), are assessed at baseline, at the end of the first week, and at the completion of the second week.
Interventions
DRUG1% Nanochitosan Solution
A novel topical formulation of chitosan nanoparticles synthesized from low-molecular-weight chitosan using the ionic gelation method, prepared as a 1 wt.% aqueous solution.
Standard commercial Nystatin oral suspension (100,000 U/mL) manufactured by Jaber Ebne Hayyan Pharmaceutical Company, utilized as the reference active control.
Sponsors
Kerman University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Commercial labels were removed from the medication bottles before delivery to maintain participant blinding.
Intervention model description
A randomized, parallel-group clinical trial to compare the efficacy of 1% nanochitosan solution with Nystatin oral suspension.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Complete denture wearers diagnosed with Newton's type II denture stomatitis. * Diagnosis verified by an oral medicine specialist. * No use of antifungal agents, antibiotics, corticosteroids, or medications that reduce salivary flow in the month prior to the study. * Willing to provide written informed consent.
Exclusion criteria
* Patients with Alzheimer's disease. * Patients with diabetes mellitus. * Patients with masticatory muscle disorders. * Patients with immunocompromising diseases. * Patients with psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in erythematous palatal mucosa lesion area | Baseline, 1 week, and 2 weeks | The total surface area of the erythematous lesion on the palatal mucosa is measured and calculated in square millimeters (mm²) to determine the reduction in denture stomatitis inflammation and evaluate clinical efficacy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in burning sensation | Baseline, 1 week, and 2 weeks | Subjective burning sensation was assessed using a Visual Analogue Scale (VAS). The scale is graded from a minimum value of 0 (no discomfort) to a maximum value of 10 (the highest rate of pain and irritation). Higher scores indicate a worse clinical outcome. |
| Microbiological findings from palatal smears | Baseline and 2 weeks | Mean count of fungal structures (mycelia and blastospores) examined via Gram-stained smears under light microscopy. |
| Overall clinical response rate | 2 weeks | Percentage of participants achieving complete recovery (total elimination of erythematous lesions) or partial recovery (reduction in erythema area). |
Countries
Iran
Outcome results
None listed